Breast cancer continues to affect approximately one woman in ten in the western world and despite the phenomenal advances in recent years the mortality rate is as high as 35%. Diagnosis of breast cancer generally involves a triple assessment process, which includes a visit to a clinic or hospital for assessment for a clinical assessment and examination, radiology imaging tests and a core needle biopsy and or Fine needle aspiration biopsy to be taken, and subsequent analysis of the biopsy by a Histopathologist or Cytologist.
Tissue core biopsies are taken using a needle punch device. The device generally comprises a needle having a hollow core and a retractable sheath. Some needle biopsy systems include a vacuum pump in fluid communication with the hollow core of the needle. In use, the device is inserted into the breast and the needle tip generally inserted into a mass within the breast with the aide of ultrasound and less frequently mammography and magnetic resonance imaging. Once in situ, retraction of the sheath causes adjacent tissue to herniate into the hollow core of the needle, whereby extension of the sheath cuts the tissue leaving a sequestered core within the needle, which is withdrawn, by the action of the vacuum pump into a collection chamber. Generally, the needle is capable of rotation about its longitudinal axis, allowing a circumferential series of core needle biopsy samples to be obtained at a desired locus. In the case of mammographic biopsies, these are usually obtained using stereotactic guidance. The core biopsies thus obtained maybe analysed by a radiologist for the presence of microcalcifications within the sequestered core biopsy samples, prior to being sent to a pathology laboratory for histological analysis by a pathologist.
The core needle biopsy device may also include a conduit for delivering variable amounts of local anaesthetic and placing a localization marker to the said sequestered outlets for delivery to the site of the extruded longitudinal strips of core biopsy tissue product and/or tissue material product.
As the histological analysis process may take several days to complete after the biopsy is taken, this necessitates that the patient has to make a first visit to the clinic or hospital for a biopsy to be taken, and a second visit to meet with the clinician to receive the diagnosis. In some cases, if the biopsy taken from the margin or satellite tissue is determined to be cancerous, further hospital visits maybe required for additional radiology imaging tests and further core biopsy needle biopsy tissue samples to be taken. It is one object of the invention to overcome at least one of these problems.
The IKNIFE is a surgical tool that helps surgeons detect cancer in a patient in real time while the patient is undergoing surgery. The IKNIFE comprises a surgical knife having a heating element that is capable of converting tissue to gaseous tissue molecules (ionization), a mass spectrometer, and a vacuum pump and conduit configured to convey the ionized tissue to the mass spectrometer where the gaseous ions are analysed to determine whether the tissue is cancerous. The device is used during surgery to resect tumours, and in particular to cut away margins and simultaneously determine in real time whether the margins are cancerous or not. The IKNIFE device is described in WO2010136887. Methods for subcellular analysis by laser ablation electrospray mass spectrometry are described in US2011/0215233. Methods for analysis of non-living substrates using an electrosurgical knife to generate ions and a mass spectrometer to analyse the ions is described in GB2491486.